Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported August 14, 2024
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0104 (6 kit test) The BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with BIOFIRE¿ FILMARRAY¿ Systems. The BIOFIRE GI Panel is capable of the simultaneous detection and identification of nucleic acids from multiple bacteria, viruses, and parasites directly from st
Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
BioFire Diagnostics, LLC recalled BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE… - a moderate-severity action.
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE… was recalled by BioFire Diagnostics, LLC in August 14, 2024. Reason: Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium.. Check the official notice for the remedy. Verify recall #Z-2514-2024 with the FDA Devices before acting.
The recall
BioFire Diagnostics, LLC issued this moderate-severity FDA Devices recall-Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium..
- Moderate
- severity level
- Class II
- classification
- August 14, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2514-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2514-2024) was formally reported on August 14, 2024, with the manufacturer initiating the action on May 16, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. BioFire Diagnostics, LLC is listed as the recalling firm, operating out of Salt Lake City, UT. Federal records list the affected scope as 67,613 kits (or 2,028,309 pouches). Each pouch is used for each individual test..
The documented reason for this recall is: Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium. Distribution data in the federal record shows the product reached: U.S.: Nationwide - AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, Vir…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
67,613 kits (or 2,028,309 pouches). Each pouch is used for each individual test.
Related Recalls
6
3 from same agency
Product description
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0104 (6 kit test) The BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with BIOFIRE¿ FILMARRAY¿ Systems. The BIOFIRE GI Panel is capable of the simultaneous detection and identification of nucleic acids from multiple bacteria, viruses, and parasites directly from stool samples in Cary Blair transport media obtained from individuals with signs and/or symptoms of gastrointestinal infection.
Reason for recall
Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2514-2024 |
| Date reported | August 14, 2024 |
| Date initiated | May 16, 2024 |
| Recalling firm | BioFire Diagnostics, LLC |
| Firm location | Salt Lake City, UT |
| Affected scope | 67,613 kits (or 2,028,309 pouches). Each pouch is used for each individual test. |
| Distribution | U.S.: Nationwide - AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, Virgin Island, VT, WA, … |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2514-2024) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0104 (6 kit test) The BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with BIOFIRE¿ FILMARRAY¿ Systems. The BIOFIRE GI Panel is capable of the simultaneous detection and identification of nucleic acids from multiple bacteria, viruses, and parasites directly from stool samples in Cary Blair transport media obtained from individuals with signs and/or symptoms of gastrointestinal infection.. Recalled by BioFire Diagnostics, LLC. Units affected: 67,613 kits (or 2,028,309 pouches). Each pouch is used for each individual test..
Why was this product recalled? ▼
Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 14, 2024. Severity: Moderate. Recall number: Z-2514-2024.
Where was the recalled product distributed? ▼
Distribution: U.S.: Nationwide - AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, Virgin Island, VT, WA, WI, WV, and WY. O.U.S.: Worldwide - AR, AU, AT, BE, BR, CA, CL, HK, CN, CO, CZ, DE, FI, FR, GR, HU, IN, IT, JP, MX, NL, NO, PH, PL, PT, SG, ZA, KR, ES, SE, CH, TW, TH, TR, GB, AL, DZ, AO, AM, BH, BY, BO, BA, BW, BG, CR, HR, CY, CD, DO, AN, EC, SV, EE, FJ, GE, GU, GT, GN, HT, HN, IS, ID, IQ, IE, IL, CI, CI, JO, KE, KW, LV, LB, LT, MO, MY, ML, MR, MD, MN, MA, MM, NP, NZ, NZ, NI, OM, PK, PA, PG, PY, PE, QA, RO, SA, RS, SI, TN, TR, UY, AE, VE, VN, and ZW..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2514-2024) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 14, 2024. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.